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  • #31
    Here's the SEAS protocol (if you don't want to read, the summary is that exercise is prescribed in "curves likely to progress" - mainly those of at least 15 degrees. Bracing begins at 35 degrees. So, the additional cost is for children with curves between 15 and 35 degrees - basically, those in the wait and watch group):

    "Exercises immediately follow observation alone, and come before bracing106. Several formulae in the literature have been developed to calculate the risk of scoliosis progression, but they have all been derived from populations with a high degree of scoliosis, with the avoidance of surgery being the primary objective. Our aim with exercises is to avoid or at least postpone bracing, and to arrive at the end of growth with a presumably stable curvature (as much as possible far from 30°, so that a value between 20° and 25° can be acceptable).74 Therefore, these formulae cannot be applied, and the risk of progression is considered looking at a combination of factors, including:

    - There is evidence of scoliosis progression coming from radiographs and/or clinical changes superior to the known measurement error (5° for radiographs, 2° for Bunnell, 3 mm for hump height);56,120

    - The starting radiographic and clinical data are near to previously defined acceptable boundaries (i.e. around 15° Cobb, or 5° Bunnell, or 5 mm of hump);106 these points should be considered provisional and should be better understood in the future with new research;

    - There is a very high postural component, as evidenced by an important decompensation and/or by the Aesthetic Index;194

    - There are high risks due to other known factors of progression, such as a family history of an important scoliosis, flat back, start of puberty, etc.16,74,169.

    On the other hand, i.e., when looking at the highest boundaries for exercise treatment we must consider that as far as we know today, exercises do not reduce the curvature105 (even if recently we ourselves raised some doubts about this hypothesis)119 nor, importantly, change the cosmetic appearance.119 So, exercises should never be proposed (in favour of bracing) when 30° curves have been attained unless the pubertal growth spurt is very far in the future and an important postural component is presumed, with the only aim of postponing (possibly avoiding) bracing.106 Moreover, exercises should be proposed when there are uncertainties regarding the application of a brace, even in curvatures exceeding 25°, and there is the possibility of stability due to the absence of other progression factors and a relatively advanced age. In such cases it is important to decide together with the patient and his/her family. Regardless, due to the very short period of research in this field177 all these points will have to be thoroughly studied and refined in the future.

    When a brace has already been prescribed, exercises are mandatory in order to avoid all side effects of bracing, to increase its function, and to allow the spine to be stable during the weaning period and when the brace is abandoned.106,136 These points are thoroughly discussed elsewhere in this chapter."

    Comment


    • #32
      Linda raises some interesting points. The cost issue is probably one reason why exercise is not used more. It's not proven so why spend the money? That's very valid.

      Some numbers I was able to find... in 2000 there were 40 million 10-17 year olds in the US. Approx. 2.5% of the adolescent population (1 million) have >10° curve. The rate drops dramatically for >20° - .23%. So of the million kids with AIS only about 92k require treatment. 40k require surgery. These are not annual numbers. You could probably divide by 7 or 8 and get a rough annual estimate. But I found that the annual rate is quite sporadic.

      I don't think anyone would suggest treating the entire 1 million kids. There are patients with a low risk for progression and those with a high risk for progression. SOSORT has a very thorough treatment guideline relative to progression risk and suggests beginning treatment at >15° and zero to low signs of maturity with exercise therapies first.

      If an exercise therapy could reduce the .23% number who require treatment, i.e. bracing, down to .18% that stops 20k kids from getting a brace. That's $100 million ($5k/brace). Offset the cost with the cost of PT by $20 million ($1k/year), that's $80 million in savings that was going to be spent. The crux is to find out how many patients with a high risk for progression, but wouldn't end up progressing, there are in the W&W group. This would be the number of theoretical over spending.

      The reason I think treatment needs to start earlier is that >20° the disc and vertebral wedging are significantly increased. Obviously, the less wedging the better. I also feel that exercise has a better chance with these smaller curves. This is also why rotational strength training was so attractive. It's simple, can be taught very quickly and is easily transferred to a home therapy protocol. This would place minimal load on the health care/ insurance system.

      I think the economics are there. The data just needs to be stronger.

      Comment


      • #33
        Originally posted by hdugger View Post
        What I meant is that, bracing is now being offered as part of regular medical treatment. We're discussing the additional cost of alternative treatment. So, the "alternative" treatment for this cohort is exercise. Once/if their curves progress enough to require bracing, they'd enter the traditional "medical" cost. Type of brace doesn't effect this cost, as far as I know.

        So, only the cost for exercise ($1000 per child) is new. All of the other costs - bracing and surgery - are the traditional medical costs that we're trying to avoid by prescribing exercise for children with smaller curves.

        Beyond that, it's hard to run the evaluation, because Linda's numbers assume every child will be braced, and that's not in accord with any protocol I know. Since I don't have any idea what percentage of children go on to be braced, I can't estimate those numbers at all. But, roughly, the idea is that, if exercise works (big if) you avoid not only the cost of bracing and possibly surgery in children, but you also avoid the burden of other back problems in both pre and post surgical adult scoliosis patients. I can't imagine that those numbers would not work out in exercise's favor (again, if exercise works to keep small curves from progressing).
        Okay I see what you are saying.

        In re your last point... whether or not exercise is effective at keeping small curves small, again, someone correct me if I'm wrong but we are talking the vast majority of curves are small. And according to that Greek study, IIRC at least 25% (or all curves but presumably most small curves) will not only not progress but will decrease spontaneously, some to zero degrees. Taking all the small curves, I think it is fair to say maybe ~90% will never progress to surgery and some large fraction of that number will not progress to brace no matter what you do or don't do.

        When the vast majority of a treatment groups (in this case kids with small curves) will never progress to needing treatment anyway, everything will look like it works, including eating ice cream. This is why I am suspicious of the Clear and their push to identify and treat small curves... I think they realize even if the treatment is completely ineffective, it will appear to work almost all the time. And then through word of mouth they will rake in bazillions. How will a PT study ever see a statistically significant difference between 90% apparently cured but who really didn't need treatment and maybe an extra 5% cured though PT? I suggest the population size is not doable to show that.

        I exempt legitimate researchers from this criticism because they are trying to be scientific about it and they obviously understand the problem on the table. There is nothing scientific about Clear.
        Sharon, mother of identical twin girls with scoliosis

        No island of sanity.

        Question: What do you call alternative medicine that works?
        Answer: Medicine


        "We are all African."

        Comment


        • #34
          Thanks, Kevin. Those number make sense to me.

          Is side-shifting also useful for those small curves? I'm wonder if we had a few simple, cheap, exercises people could try (and a few is better than one to cover the different types of curves/responses) that might keep them from ever reaching that 20 degree mark, we could reduce the disease burden even further. I guess I'm looking at something that could be easily summarized by a flyer you could get out to those school nurses screening for scoliosis.

          Of course, all of these assumes somehow showing that these exercises slow progression.

          Comment


          • #35
            Originally posted by Pooka1 View Post
            Taking all the small curves, I think it is fair to say maybe ~90% will never progress to surgery and some large fraction of that number will not progress to brace no matter what you do or don't do.
            Yes, that's what Kevin's numbers suggest.

            Clear is obviously (clearly ) overkill for curves under 15 or 20 degrees. In that range, you really just want some simple, cheap exercise you can explain in a few minutes. You'd have to study the effectiveness of the exercse, though, on larger curves, for the reasons you outline. But, if you can show that a few simple exercises keep some percentage of larger curves from progressing, you might reasonably assume that they'd also work on smaller curves.

            The real test of this kind of strategy comes over time and huge numbers of patients in a natural study. If the protocol for small curves changes from 'watch and wait' to "do these exercises" and, over years, the rate of small curves progressing to large curves goes down, then you might suspect that these measures worked. But, yes, it is very hard to prove these kinds of things.

            Comment


            • #36
              Originally posted by hdugger View Post
              You'd have to study the effectiveness of the exercse, though, on larger curves, for the reasons you outline. But, if you can show that a few simple exercises keep some percentage of larger curves from progressing, you might reasonably assume that they'd also work on smaller curves.
              Yes but as we have seen, progression even in large curves (viz my one daughter's several month long quasi-stability in the mid-30s*, a period which exceeds the duration of the torso rotation and many other studies), cannot be assumed. That's why I am persuaded by your approach that the only hope to try to see some PT effect is a reduction in a large curve, NOT stability only during a few weeks to months.

              The real test of this kind of strategy comes over time and huge numbers of patients in a natural study. If the protocol for small curves changes from 'watch and wait' to "do these exercises" and, over years, the rate of small curves progressing to large curves goes down, then you might suspect that these measures worked. But, yes, it is very hard to prove these kinds of things.
              Yes I suspect you are correct.

              Here's a thought, isn't there some way to identify kids in the peak height velocity in real time? I think if you can get enough kids determined to be in this stage to participate in even a short-term PT study, it might be significant. Don't know.
              Sharon, mother of identical twin girls with scoliosis

              No island of sanity.

              Question: What do you call alternative medicine that works?
              Answer: Medicine


              "We are all African."

              Comment


              • #37
                Actually, with something like exercise which isn't part of the standard protocol, it would be far simpler to do a real randomized study. That is, unlike bracing, you're not fighting doctors who feel that they should be prescribing it, or teenagers who are fighting being braced.

                So, you could do a simple randomization - one kid gets the exercise treatment and the next kid doesn't - without running into any of the usual ethical questions.

                The problems of having a variable course of disease is true of almost all medical issues. (Two people with the same kind of cancer at the same stage, for example, can progress at quite different rates.) A well-designed experiment with an adeqate number of patients should show an effect if exercise actually makes a difference. So, it's not at all hopeless. You just need to get an adequate number of patients. If you could interest some place that sees alot of patients (like Shriners), you could get those numbers pretty easily.

                Comment


                • #38
                  Identifying peak velocity is a great question. Even having a good handle on which kids are likely to progress would be helpful.

                  Comment


                  • #39
                    Originally posted by hdugger View Post
                    We're already bracing kids with curves of a certain size. So, you're double-counting in alternative treatment something that's already a part of standard treatment.

                    All that's being added is exercise. PT is already standard treatment for other back problems, and it has significantly reduced the cost of treating back problems.
                    Nope. I'm saying that there are 200,000 new cases of scoliosis each year where the curves fall outside of the treatment protocol. That is, their curves are too small to warrant treatment.
                    Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
                    ---------------------------------------------------------------------------------------------------------------------------------------------------
                    Surgery 2/10/93 A/P fusion T4-L3
                    Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

                    Comment


                    • #40
                      Originally posted by skevimc View Post
                      I think the economics are there. The data just needs to be stronger.
                      The economics are definitely there if we can identify the kids that are at risk of progression. While most of the group discussing this current topic are talking about exercise alone, there are certainly a lot of the folks who are usually involved in these discussions, who think that all W&W kids should be braced.

                      --Linda
                      Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
                      ---------------------------------------------------------------------------------------------------------------------------------------------------
                      Surgery 2/10/93 A/P fusion T4-L3
                      Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

                      Comment


                      • #41
                        Originally posted by Pooka1 View Post
                        Okay I see what you are saying.

                        In re your last point... whether or not exercise is effective at keeping small curves small, again, someone correct me if I'm wrong but we are talking the vast majority of curves are small. And according to that Greek study, IIRC at least 25% (or all curves but presumably most small curves) will not only not progress but will decrease spontaneously, some to zero degrees. Taking all the small curves, I think it is fair to say maybe ~90% will never progress to surgery and some large fraction of that number will not progress to brace no matter what you do or don't do.

                        When the vast majority of a treatment groups (in this case kids with small curves) will never progress to needing treatment anyway, everything will look like it works, including eating ice cream. This is why I am suspicious of the Clear and their push to identify and treat small curves... I think they realize even if the treatment is completely ineffective, it will appear to work almost all the time. And then through word of mouth they will rake in bazillions. How will a PT study ever see a statistically significant difference between 90% apparently cured but who really didn't need treatment and maybe an extra 5% cured though PT? I suggest the population size is not doable to show that.

                        I exempt legitimate researchers from this criticism because they are trying to be scientific about it and they obviously understand the problem on the table. There is nothing scientific about Clear.
                        Well said. Thanks.
                        Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
                        ---------------------------------------------------------------------------------------------------------------------------------------------------
                        Surgery 2/10/93 A/P fusion T4-L3
                        Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

                        Comment


                        • #42
                          Originally posted by LindaRacine View Post
                          The economics are definitely there if we can identify the kids that are at risk of progression. While most of the group discussing this current topic are talking about exercise alone, there are certainly a lot of the folks who are usually involved in these discussions, who think that all W&W kids should be braced.
                          I agree there is a somewhat casual insouciance towards bracing kids. Bracing is far from benign and yet I think there are people here and elsewhere who would brace their kid if the chance of avoiding surgery was known and was 1% or even 0.1%. That might have been rational before the pedicle screw era but I think making the ethical case for the rationality of that now is very hard.
                          Last edited by Pooka1; 01-22-2010, 06:42 PM.
                          Sharon, mother of identical twin girls with scoliosis

                          No island of sanity.

                          Question: What do you call alternative medicine that works?
                          Answer: Medicine


                          "We are all African."

                          Comment


                          • #43
                            Originally posted by Pooka1 View Post

                            Here's a thought, isn't there some way to identify kids in the peak height velocity in real time? I think if you can get enough kids determined to be in this stage to participate in even a short-term PT study, it might be significant. Don't know.
                            Accurate record keeping by the doctor's office would be able to calculate this when they come in. If I can remember correctly, 9 cm/yr is considered pretty close to peak for most kids. It would be easy to measure it yourself at home. (Height B - Height A)*(12/number of months between A and B).

                            We reported PHV. There were 2 who had velocities of 13 cm/yr, one girl one boy. Both had left TL/L, 21° and 31° respectively. Risser II and 0 respectively. Both reduced, 15° and 24°. The girl maintained her correction, risser V. The boy was a yo-yo. He reduced the first interval (26°). Stopped working out, progressed (35°). Started working out again, reduced (24°) - final measurement we had.

                            Then there were others with PHV ~7cm/yr who progressed by a year or so out.

                            It's interesting looking at the data again. I haven't for a long time. There were some progressions I hadn't remembered. It makes me remember how confusing and random everything seemed. One girl specifically I think of who did everything we asked of her. Worked out hard. Got a lot stronger after training. Progressed 10° 12 months out. Those are visits where you just want to become invisible. Those are the experiences I remember and become fairly agitated at websites (and other things) that say they have 100% success. They aren't reporting the full story.

                            Comment


                            • #44
                              Okay that was pretty interesting. But isn't peak height velocity as determined by sequential height measurements going to underestimate the velocity in the case of a progressive curve? Maybe it isn't significant enough such that the phase is missed using this approach, I don't know.
                              Sharon, mother of identical twin girls with scoliosis

                              No island of sanity.

                              Question: What do you call alternative medicine that works?
                              Answer: Medicine


                              "We are all African."

                              Comment


                              • #45
                                Originally posted by LindaRacine View Post
                                Nope. I'm saying that there are 200,000 new cases of scoliosis each year where the curves fall outside of the treatment protocol. That is, their curves are too small to warrant treatment.
                                I posted the SEAS protocol, and that's the one I would (personally) recommend. Their protocol has exercise from 15 to 35, and bracing after that. That's an alternative course, but one where the bracing falls within the standard protocol.

                                Given that protocol, only the cost of exercise for patients between 15 and 35 degrees would be added to the current protocol. I think Kevin's post breaks down those costs very well.

                                All of this, of course, is for AIS only. The risk of progression for JIS is so elevated that you might have to shift the treatment window much earlier in order to keep those kids from progressing.

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